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Prevention of deep vein thrombosis with low molecular-weight heparin in patients undergoing total hip replacement

A randomized trial

Summary

In a double-blind, randomized multicentre trial, the efficacy and safety of two regimens for the prevention of postoperative venous thrombo-embolism, low-molecular-weight heparin (LMWH) CY 216 and unfractionated heparin (UH), were compared in 341 patients undergoing elective total hip replacement. A group of 169 patients received one subcutaneous injection of 48 mg (≈ 10 000 anti-Xa IC units) LMWH and two placebo injections per day and 172 patients received a fixed dose of 5000 IU UH t.i.d. Deep vein thrombosis was assessed by bilateral phlebography on day 14 ± 1 after surgery. Phlebography was successfully performed in 136 patients in the LMWH group and 137 patients in the UH group. Deep vein thrombosis occurred in 45 of 137 patients (33.1%) treated with LMWH CY 216 and in 47 of 136 patients (34.3%) who received UH. Pulmonary embolism occurred in 2 of 167 evaluable patients (1.2%) in the LMWH group and in 6 of 168 patients (3.6%) in the UH group. In addition, the incidence of proximal deep vein thrombosis was evaluated and was found to be 10.3% (14/137 patients) in the LMWH group and 19% (26/136 patients) in the UH group (P = 0.044, two-sided). The safety of the treatments, as assessed by the incidence of major haemorrhage, intra- and postoperative blood loss, transfusion requirements, haemoglobin drop and frequency of wound haematomata, was similar in the two groups. It is concluded that prophylaxis of postoperative thrombo-embolism in hip surgery with one subcutaneous injection (48 mg) of LMWH CY 216 is as effective and as safe as prevention with fixed low-dose heparin (5000 IU t.i.d). A tendency to reduced rates of pulmonary embolism (3.6% vs. 1.2%) and proximal deep vein thrombosis (19% vs. 10.3%) was observed in favour of LMWH CY 216.

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References

  1. 1.

    Bansillon V, Dejour H, Besson L, Davidas JL, Rondelet B, Azzar D, Massignon D (1987) Prévention des thromboses veineuses profondes en chirurgie orthopédique poor mise en place d'une prothèse totale de hanche. Essai randomisé de détermination de la posologie optimale. Ann Chir 41:377–385

  2. 2.

    Bergqvist D (1983) Postoperative thromboembolism. Springer, Berlin Heidelberg New York

  3. 3.

    Collins R, Scrimgeour A, Yusuf S, Peto R (1988) Reduction in fatal pulmonary embolism and venous thrombosis by peri-operative administration of subcutaneous heparin. N Engl J Med 318:1162–1173

  4. 4.

    Dechavanne M, Ville D, Berruyer M, Trepa F, Dalery F, Clermont N, Lerat JL, Moyen B, Fischer LP, Kher A, Barbier P (1989) Randomized trial of a low molecular weight heparin (Kabi 2165) versus adjusted-dose-subcutaneous standard heparin in the prophylaxis of deep-vein thrombosis after elective hip surgery. Haemostasis 1:5–12

  5. 5.

    Dejour H, Bansillon V, Simon P (1988) Prevention of deep vein thrombosis (DVT) and pulmonary embolism (EP) in elective orthopaedic surgery for total hip replacement (THR) by a low molecular weight heparin: Fraxiparine. Abstract. Xth International Congress on Thrombosis, Athens

  6. 6.

    Eriksson BI, Zachrisson BE, Teger-Nilsson AC, Risberg B (1988) Thrombosis prophylaxis with low molecular weight heparin in total hip replacement. Br J Surg 75:1053–1057

  7. 7.

    European Fraxiparin Study (EFS) Group (1988) Comparison of a low molecular weight heparin and unfractionated heparin for the prevention of deep vein thrombosis in patients under-going abdominal surgery. Br J Surg 75:1058–1063

  8. 8.

    Evarts CM, Alfidi RJ (1973) Thromboembolism after total hip reconstruction. Failure of low doses of heparin in prevention. JAMA 225:515–516

  9. 9.

    Francis CW, Marder VJ, Evarts CM (1986) Lower risk of thromboembolic disease after total hip replacement with noncemented than with cemented prostheses. Lancet 769–771

  10. 10.

    Hach W (1985) Phlebographie der Bein- und Beckenvenen. Schnetztor, Konstanz

  11. 11.

    Hauck WW, Anderson S (1986) A comparison of large-sample confidence interval methods for the difference of two binomial probabilities. Am Stat 40:318–322

  12. 12.

    Hauck WW, Anderson S (1986) Proposal for interpreting and reporting negative studies. Star Med 5:203–209

  13. 13.

    Kakkar VV, Murray WJG (1985) Efficacy and safety of lowmolecular-weight heparin (CY 216) in preventing postoperative venous thrombo-embolism: a co-operative study. Br J Surg 72:786–791

  14. 14.

    Kakkar VV, Corrigan TP, Fossard DP (1975) Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicenter trial. Lancet 7924–7930

  15. 15.

    Kakkar VV, Fok PJ, Murray WJG, Paes T, Merenstein D, Dodds R, Farrell R, Crellin RQ, Thomas EM, Morley TR, Price AJ (1985) Heparin and dihydroergotamine prophylaxis against thrombo-embolism after hip arthroplasty. J Bone Joint Surg [Br] 67:538–542

  16. 16.

    Larsen ML, Abilgaard U, Teien AN, Gjesdal K (1978) Assay of plasma heparin using thrombin and the chromogenic substrate H-D-Phe-Pip-Arg-pNA (S-2238). Thromb Res 13:285–288

  17. 17.

    Lassen MR, Borris LC, Christiansen HM, Møller-Larsen F, Knudsen VE, Boris P, Nehen AM, Carvalho A de, Jurik A-G, Nielsen BW, Lucht U (1988) Heparin/dihydroergotamine for venous thrombosis prophylaxis: comparison of low-dose heparin and low molecular weight heparin in hip surgery. Br J Surg 75:686–689

  18. 18.

    Leyvraz PF, Bachmann F, Hoek J, Büller HR, Postel M, Samama M, Vandenbroek MD (1991) Prevention of deep vein thrombosis after hip replacement: randomised comparison between unfractionated heparin and low molecular weight heparin. Br Med J 303:543–548

  19. 19.

    Leyvraz PF, Richard J, Bachmann F, Van Melle G, Treyvaud JM, Livio JJ, Candardjis G (1983) Adjusted versus fixed-dose subcutaneous heparin in the prevention of deep-vein thrombosis after total hip replacement. N Engl J Med 309:954–958

  20. 20.

    Lormeau JC, Hajjar R (1988) Méthode de titrage de l'activité anti-facteur Xa du CY 216. Pathol Biol (Paris) 36:335–337

  21. 21.

    Mayer W (1967) Thromboembolie-Prophylaxe in der Chirurgie. Schattauer, Stuttgart

  22. 22.

    Modig J, Maripu E, Sahlstedt B (1986) Thromboembolism following total replacement. A prospective investigation of 94 patients with emphasis on the efficacy of lumbar epidural anesthesia in prophylaxis. Reg Anaesth 11:72–79

  23. 23.

    Moser KM (1977) Pulmonary embolism. Am Rev Resp Dis 115:829

  24. 24.

    Moskovitz PA, Ellenberg SS, Feffer HL, Kenmore PI, Neviaser RJ, Rubin BE, Varma VM (1978) Low dose heparin for prevention of venous thromboembolism in total hip arthroplasty and surgical repair of hip fractures. J Bone Joint Surg [Am] 60:1065–1070

  25. 25.

    Owens EL, Kasten GW, Hessel EA (1986) Spinal subarachnoid hematoma after lumbar puncture and heparinization: a case report, review of literature, and discussion of anesthetic implications. Anesth Analg 65:1201–1207

  26. 26.

    Pezzuoli G, Neri Serneri GG, Settembirni P, Coggi G, Olivari N, Buzzetti G, Chierichetti S, Scotti A, Scatigna M, Carnovali M and the STEP Study Group (1989) Prophylaxis of fatal pulmonary embolism in general surgery using low-molecular-weight heparin CY 216: a multicentre, double-blind, randomized, controlled clinical trial versus placebo (STEP). Int Surg 74:205–210

  27. 27.

    Planes A, Vochelle N, Mazas F, Mansat C, Zucman J, Landais A, Pascariello JC, Weill D, Butel J (1988) Prevention of postoperative venous thrombosis: a randomized trial comparing unfractionated heparin with low molecular weight heparin in patients undergoing total hip replacement. Thromb Haemost 60:407–410

  28. 28.

    Rabinov K, Paulin S (1972) Roentgen diagnosis of venous thrombosis in the leg. Arch Surg 104:134–144

  29. 29.

    Sagar S, Nairn D, Stamatakis JD, Maffei FH, Higgins AF, Thomas DP, Kakkar VV (1976) Efficacy of low-dose heparin in prevention of extensive deep-vein-thrombosis in patients undergoing total-hip-replacement. Lancet 1151–1154

  30. 30.

    Salzman EW, Harris WH (1976) Prevention of venous thromboembolism in orthopaedic patients. J Bone Joint Surg [Am] 58:903–913

  31. 31.

    Sevitt S, Gallagher NG (1961) Venous thrombosis and pulmonary embolism. A clinicopathological study in injured and burned patients. Br J Surg 48:475

  32. 32.

    Simon P, Kindermans A, Kempf JF, Postel F (1990) Efficacité et tolérance de la Fraxiparine dans la prévention des thromboses veineuses profondes lots des arthroplasties totales de hanche réglées. Essai prospectif, multicentrique. J Chir (Paris) 127:252–257

  33. 33.

    Turpie AGG, Levine MN, Hirsh J, Carter CJ, Jay RM, Powers PJ, Andrew M, Hull RD, Gent M (1986) A randomized controlled trial of a low-molecular-weight heparin (Enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. N Engl J Med 15:925–959

  34. 34.

    Weber J, May R (1990) Funktionelle Phlebologie. Phlebographie, Funktionstests, interventionelle Radiologie. Thieme, Stuttgart

  35. 35.

    Williams JW, Eikman EA, Greenberg SH, Hewitt JC, Lopez-Cuenca E, Jones GP, Madden JA (1987) Failure of low dose heparin to prevent pulmonary embolism after hip surgery or above the knee amputation. Ann Surg 188:468–474

  36. 36.

    Yin ET, Wessler S, Butler JV (1973) Plasma heparin: a unique, practical, submicrogram-sensitive assay. J Lab Clin Med 81:298–310

  37. 37.

    Zachrisson BE, Jansen HJ (1973) Phlebographic signs in fresh postoperative venous thrombosis of the lower extremity. Acta Radiol (Diagn) 14:82–96

  38. 38.

    Zimmermann H, Frick H, Rahlfs VW: Test for equivalence, an overview and comparison. IDV-Datenanalyse und Versuchsplanung, Gauting, Munich (internal report no 6)

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Prevention of deep vein thrombosis with low molecular-weight heparin in patients undergoing total hip replacement. Arch Orthop Trauma Surg 111, 110–120 (1992). https://doi.org/10.1007/BF00443477

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Keywords

  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Subcutaneous Injection
  • Unfractionated Heparin
  • Transfusion Requirement